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 The United States is firmly of the view that international obligations such as those in the TRIPS Agreement have sufficient flexibility to allow trading partners to address the serious public health problems that they may face. The United States strongly supports the WTO TRIPS/health solution concluded in August 2003, in which members are permitted, in accordance with specified procedures, to issue compulsory licenses to export pharmaceutical products to countries that cannot produce drugs for themselves. The General Council adopted a Decision in December 2005 that incorporated this solution into an amendment to the TRIPS Agreement, and later that month the United States became the first WTO member to formally accept this amendment. The United States hopes that at least two-thirds of the WTO membership accept this amendment by the December 31, 2013 deadline, at which point the amendment will go into effect for those accepting members. The August 2003 waiver will remain in place and available until the amendment takes effect.

The United States will work to ensure that the provisions of its bilateral and regional trade agreements, as well as U.S. engagement in international organizations, including the United Nations and related institutions such as WIPO and the World Health Organization, are consistent with U.S. Government policies concerning IPR and health policy and do not impede its trading partners from taking necessary measures necessary to protect public health. Accordingly, USTR will continue its close cooperation with relevant agencies to ensure that public health challenges are addressed and IPR protection and enforcement are supported as mechanisms to promote research and innovation.

To further this cooperation, USTR has convened a new subcommittee of the interagency Trade Policy Staff Committee, called "Trade Enhancing Access to Medicines" (TEAM), which is intended to further facilitate communication and collaboration toward this shared objective. With the understanding that trade policy tools can impact only some of the relevant issues, the subcommittee is designed to investigate how to best deploy the tools of trade policy to further the Administration's objective of promoting trade in, reducing obstacles to, and enhancing access to both innovative and generic medicines. The subcommittee is currently composed of representatives of diverse offices within the United States Government, including, those from: the Office of the Global AIDS Coordinator, International Health and Biodefense, USAID, and the Bureau for Economic Affairs, within the Department of State; the Office of Global Affairs, and the Food and Drug Administration, within the Department of Health and Human Services; the Department of Commerce; the Department of the Treasury; and several government officials with relevant expertise.

Supporting Pharmaceutical and Medical Device Innovation through Improved Market Access

Among other mechanisms to support pharmaceutical and medical device innovation, USTR has sought to reduce market access barriers that U.S. pharmaceutical and medical device companies face in many countries, and to facilitate both affordable health care today and the innovation that assures improved health care tomorrow. For example, this year's Special 301 Report highlights concerns regarding market access barriers affecting pharmaceutical products in Algeria and Indonesia. 20